Cayston is administered at a dose of 75mg three times daily over a 28-day period and is delivered via the Altera Nebulizer System, a portable, drug-specific delivery device using the eFlow Technology platform, developed by Pari Pharma.
Pari Pharma has also contributed to the development of Cayston’s drug formulation for delivery with the Altera Nebulizer System. Cayston will be available in the US by the end of next week through certain specialty pharmacies.
Norbert Bischofberger, executive vice president and chief scientific officer of research and development at Gilead, said: “All of us at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials. We look forward to making Cayston available to the cystic fibrosis community as soon as possible.”
Robert Beall, president and CEO of Cystic Fibrosis Foundation, said: “As the first new inhaled antibiotic approved for use in cystic fibrosis in more than a decade, Cayston therefore represents an important therapeutic option in the care of patients with cystic fibrosis.”
Cayston received conditional marketing authorisations in the EU and Canada in September 2009 and was approved in Australia in January 2010. Applications for marketing approval of Cayston are currently pending in Switzerland and Turkey.